Kornimate/medical-research-clean huggingface dataset:
clinical study of et190l1 artemis™ in relapsed, refractory b cell lymphoma

Conditions: Lymphoma, B-Cell

Summary: this study is to determine the safety, including potential dose limiting toxicities, of et190l1 artemis™ t cells and the duration of in vivo survival of et190l1 artemis™ t cells in patients with relasped/refractory b-cell lymphoma. for patients with detectable disease, the study will also measure anti-tumor responses after et190l1 artemis™ cell infusions.

et190l artemis™ is a novel chimeric t-cell therapy platform that in preclinical studies, functionally matches the efficacy of car t cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.

Eligibility criteria:
inclusion criteria: * patients with relapsed/refractory cd19+ b-cell lymphoma, with no effective therapy available per nccn guidelines * no hcv, hiv infection, no active hbv * liver and kidney function: alanine aminotransferase (alt) and aspartate aminotransferase (ast) does not exceed five times the upper limit of normal range. alt \<200u / l, bilirubin \<2.0 mg/ dl * renal function: creatinine \<2.5mg / dl; pre-treatment absolute creatinine clearance ≥50 ml / minute * cbc: hemoglobin ≥ 80g / l, absolute neutrophil counts ≥1 × 10\^9 / l, platelets ≥50 × 10\^9 / l * echocardiography or multiple gated angiogram (muga) ejection fraction\> 45% * ecog performance status ≤2, expected survival time \> 3 months per pis opinion * women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose. * had a recurrence after at least a first-line systemic treatment * peripheral venous access is available and no issues with apheresis for lymphocyte isolation * voluntarily signed informed consent form exclusion criteria: * women in pregnancy and lactation * unable to perform leukapheresis and iv infusion * with active infection * major organ failure * continuously used glucocorticoids or other immunosuppressive agents within 4 weeks * t cell deficiency or t cells are difficult to be transduced

Keywords: relapsed/refractory cd19+ lymphomas, b-cell
endocrine changes in adults undergoing cardiac surgery

Conditions: Endocrine System Diseases; Cardiac Surgery; Quality of Life; Psychology, Social

Summary: in this prospective study the investigators want to measure the serum level changes of the thyroid hormones (thyroid-stimulating hormone, reverse triiodothyronine, serum free t4), brain natriuretic peptide (bnp), testosterone and sexual hormone binding protein (shbg) in adults undergoing cardiac surgery and search for correlations different psychosocial factors and analyze the influence on the survival and the length of icu/hospital stay.

in this study the investigators want to analyze routinely collected data of patients who underwent any kind of elective cardiac surgery in our university cardiovascular centre between 07.01.2018 and 30.06.2020. the database contains descriptive parameters, history of past illnesses, recent medication. the investigators record the type of surgery, the list of contributory physicians, the length of the surgery and the data of the anaesthesiological report. after the surgery the researchers want to record the postoperative parameters on the icu ( infusion - fluid balance, blood transfusion, bleeding, main hemodynamic parameters, length of mechanical ventilation,main parameters of arterial blood gas analysis). moreover th investigators want to collect psychosocial tests (beck depression inventory, state anxiety scale, trait anxiety scale and eq-5d for the measurement of quality of life) to get more information from the postoperative condition of the patients.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery exclusion criteria: * lack of consent * pregnancy * acute surgery * exposition with iodin-containing contrast material
a study to assess effectiveness and safety of fixed dose combination of lopinavir/ritonavir (lpv/r) in human immunodeficiency virus type 1 (hiv-1) infected patients after switching from kaletra in the routine clinical settings of russian federation

Conditions: HIV-1 Infection

Summary: this is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of lopinavir/ritonavir (lpv/r) after switching from kaletra in the routine clinical settings of russian federation.


Eligibility criteria:
inclusion criteria: * human immunodeficiency virus type-1 (hiv-1) infected patients on any dual or triple highly active anti-retroviral therapy (haart) with kaletra under observation at least 48 weeks and with two consequent plasma hiv-1 rna levels within the last 24 weeks (plasma hiv-1 rna level \<50 copies/ml) switched to a generic lpv/r as decided by the physician in the routine clinical settings within last 24 weeks from study enrollment date. * hiv-1 infected patients with last available cd4+ t-cell count test result \> 200 cells/mm3 before switching from kaletra. * other (not lpv/r) haart medicine components of dual or triple hiv therapy not planned to change by regular physician after switching to generic lpv/r. * signed inform consent form by patient. exclusion criteria: * participant has contraindications for the treatment with lpv/r. * legal or physical incapability of patient to sign inform consent form

Keywords: lopinavir/ritonavir (lpv/r) kaletra human immunodeficiency virus (hiv) generic product highly active anti-retroviral therapy (haart)
the effect of relaxation response on provider burnout

Conditions: Burnout; Resilience; Perceived Stress

Summary: hypothesis: relaxation response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. the intervention is hypothesized to moderate the relationship between areas of worklife (aws) and burnout by improving physician's ability to cope with the demands of their workplace. this increased coping ability is hypothesized to reduce burnout. physician practices are as unique as the individual practitioners and the environment in which they practice. traditional instruction of relaxation or self-care techniques has required participants to travel to locations remote from the workplace. the time commitment required for this behavior is additive to the time required to learn the intervention and of itself may induce extra stress increasing the potential for burnout. this study proposes that bringing the intervention to the workplace will increase provider willingness to participate and diminish the stress introduced by deployment of the intervention. since inpatient and outpatient medicine have different practice characteristics and demands on the time of the practitioners, this study will need to develop and test the logistics necessary to bring the training to the different physician populations.


Eligibility criteria:
inclusion criteria: * providers at designated clinic and hospital exclusion criteria: -

Keywords: burnout stress provider relaxation response
digital behavioral therapy for sleep problems

Conditions: Insomnia

Summary: insomnia is very common, especially in hiv population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. cognitive-behavioral therapy for insomnia (cbt-i) is known to improve insomnia. however, it has never been tested in hiv-positive patients. the investigators aim to examine the internet version of this therapy in hiv-positive patients because the availability of cbt-i is very limited while the cost is high. the investigators will test this internet version, also called digital cbt-i (dcbti), against sleep hygiene education (she), a commonly prescribed set of instructions in clinical practice, in 60 hiv-positive patients with insomnia invited from the multicenter aids cohort study (macs) los angeles site. the investigators aim to test if dcbti or she improves insomnia in this patient group. this trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in hiv-positive patients.


Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of insomnia disorder * aged 18 years or older * reliable internet access using either computer or smartphone * ability to read and understand english exclusion criteria: * high risk of obstructive sleep apnea * diagnosis of restless legs syndrome * severe health issues requiring hospital admission * currently receiving psychological treatment for insomnia * reporting current suicidal ideation
meditation accelerated brain stimulation for depression

Conditions: Depression

Summary: repetitive transcranial magnetic stimulation (rtms) is an fda-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (dlpfc) brain region. the ultimate goal of this treatment is to increase excitability and long-term plasticity in dlpfc, a brain region shown to be hypo-active in depression. unfortunately, rtms only has low to moderate efficacy; remission rates for patients range from \~15-30% in large randomized controlled trials. the focus of this research is to develop a next-generation rtms protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rtms for the treatment of depression. specifically, in this study the investigators will test rtms paired with a depression-relevant cognitive state of internal attention.

repetitive transcranial magnetic stimulation (rtms) is an fda-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (dlpfc) brain region. the ultimate goal of this treatment is to increase excitability and long-term plasticity in dlpfc, a brain region shown to be hypo-active in depression. unfortunately, rtms only has low to moderate efficacy; remission rates for patients range from \~15-30% in large randomized controlled trials. the focus of this research is to develop a next-generation rtms protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rtms for the treatment of depression. specifically, in this study the investigators will test rtms paired with a depression-relevant cognitive state of internal attention. meditative internal focus has been shown to benefit depression. our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. hence, in this study we will pair breath training with rtms neuro-stimulation.

Eligibility criteria:
inclusion criteria: * moderate to severe depression (phq-9 scale score \>9 with confirmation using the structured clinical interview for dsm-5 disorders) * treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode) exclusion criteria: * active substance abuse/dependence * psychotic disorders * any factor that increases risk of tms (metal implants/history of stroke/seizure disorder). * displaying acutely suicidal behaviors on the columbia suicide severity rating scale.
a study of rovalpituzumab tesirine (sc16ld6.5) in the frontline treatment of patients with extensive stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (sclc).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve sclc * dll3-expressing sclc based on central immunohistochemistry (ihc) assessment. positive is defined as staining in ≥75% of tumor cells. * eastern cooperative oncology group performance status of 0 or 1. * minimum life expectancy of at least 12 weeks. * recovery to grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug. * satisfactory laboratory parameters within defined parameters (anc, platelet count, hb, total bilirubin, alt, ast and gfr) * subjects with a history of cns metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids * use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male exclusion criteria: * prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, t-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) sclc. * any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study. * documented history of a cerebral vascular, unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association (nyha) class iii-iv within 6 months prior to their first dose of study drug. * recent or ongoing serious infection. * women who are pregnant or breastfeeding. * history of another invasive malignancy that has not been in remission for at least 3 years. exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear. * prior exposure to a pyrrolobenzodiazepine (pbd)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation
four cycles taxane with trastuzumab and pertuzumab neoadjuvant therapy among low risk her2 positive patients

Conditions: HER2-positive Breast Cancer

Summary: neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency. chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for her2 positive breast cancer patients. paclitaxel plus carboplatin (tcb) is the first choice of chemotherapy recommended by major guidelines; as an alternative, single drug taxus (t) is also listed as class i recommendation in the latest csco guidelines, but the level of evidence is slightly insufficient. in the her2 positive neoadjuvant therapy population, relatively early and low-risk patients may obtain good curative effect in the treatment of single drug taxane chemotherapy combined with double target therapy. the project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of peking university people's hospital, and retrospectively include the her2 positive breast cancer patients with clinical stage t1c, lymph node negative and receiving taxanes combined with double target neoadjuvant therapy admitted to the center from january 1, 2019 to december 31, 2024. patients of the same type were prospectively included from january 1, 2025 to december 31, 2028. objective to evaluate the efficacy and safety of taxanes combined with double target neoadjuvant therapy.


Eligibility criteria:
inclusion criteria: 1. patients with her2 positive breast cancer were diagnosed by biopsy in peking university people's hospital; 2. the clinical stages were t1c, n0, m0; 3. received treatment in our hospital and had hospitalization records; 4. has signed and agreed to participate in the pkuph breast disease cohort study; 5. it is up to the clinician to decide whether to add anthracycline chemotherapy in the adjuvant treatment stage. exclusion criteria: 1. lack of clinical and pathological data (such as imaging data and pathological data); 2. patients with metastatic breast cancer or bilateral breast cancer; 3. at the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy; 4. receiving other regimens besides the established neoadjuvant regimens

Keywords: neoadjuvant chemotherapy de-escalation
a study of a novel silicone dressing to minimize scar formation

Conditions: Hypertrophic

Summary: neodyne has developed an investigational dressing for post-operative incision care. neodyne is conducting this research to study whether the investigational dressing, called the neodyne dressing, can minimize scar formation in a simple manner.

it is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. it is expected that by managing the incision site during the healing phase, scar formation may be minimized.

Eligibility criteria:
inclusion criteria: * subjects who have undergone a de novo abdominoplasty. * appearance of subject's incision is aesthetically similar across length of incision. exclusion criteria: * subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus. * subjects diagnosed with scleroderma. * subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives. * subjects with oozing, dehiscence, non-closed/healed incisions at time of first application. * subjects with inability to maintain adequate care of incision. * subjects with a body mass index (bmi) \> 30. * subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty. * subjects who currently smoke. * subjects taking steroid therapy.

Keywords: scar incision wound healing scarring post-surgical
comparison of laryngeal mask airway (lma®) and tracheal tube in modified radical mastectomy on breast cancer

Conditions: Breast Cancer

Summary: airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. lma® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. given no need using muscular relaxants in mastectomy, the investigators hypothesized that lma® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the lma® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.


Eligibility criteria:
inclusion criteria: * chinese * diagnosed breast cancer * undergoing modified radical mastectomy * agreed to participate the study with informed contract. exclusion criteria: * organic dysfunction * long-lasting post-anesthetic care unit(pacu) staying.

Keywords: intubation, intratracheal homeostasis mastectomy, modified radical breast neoplasms
a study to assess the safety and effectiveness of flx-787 in subjects with charcot-marie-tooth disease experiencing muscle cramps.

Conditions: Charcot-Marie-Tooth Disease

Summary: the commit study will assess the safety and effectiveness of flx-787 in men and women with charcot-marie-tooth disease (cmt) experiencing muscle cramps. participants will be asked to take two study products during the course of the study. one of these study products will be a placebo. approximately 120 participants in 20 study centers across the united states are expected to take part. participants will be in the study for approximately 3 months and visit the study clinic 3 times.


Eligibility criteria:
inclusion criteria: * presence of symptoms of cmt since at least 6 months prior to screening, and confirmed diagnosis of cmt as defined by: 1. genetic confirmation of a mutation known to cause cmt, or 2. clinical and electrophysiological evidence of cmt and a genetic confirmation in a family member. clinical features include length dependent sensory and motor loss, with sensorimotor axonal or demyelinating changes on a nerve conduction study. * weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes) exclusion criteria: * presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers * presence of significant swallowing problems * unable or unwilling to discontinue medications for cramps and/or opiates * inability to tolerate a spicy sensation in the mouth or stomach * actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol * intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled) * participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening

Keywords: charcot-marie-tooth cmt muscle cramps muscle cramping flx-787 hereditary sensory and motor neuropathy neurogenetic disorder nervous system malformations nervous system diseases neurodegenerative diseases neuromuscular diseases
the relationship between second trimester placental growth factor level and fetal growth restriction

Conditions: Intra Uterine Growth Retardation

Summary: type of the study: a prospective observational study study settings: the study will be conducted at ain shams university maternity hospital, obstetrics and gynecology department, faculty of medicine over a period of six month from july 2017 to december 2017. study population: the study population comprises 60 pregnant women at 13 to 28 week of gestation attending outpatient clinic and emergency ain shams university maternity hospital, obstetrics and gynecology department, faculty of medicine. sample size justification sample size was calculated using pass 11.0 sample size calculation program and based on the study carried out by benton, et al. (2016) group sample sizes of 30 in group one (iugr) and 30 in group two (controls) achieve 80% power to detect a difference between the group proportions of 0.2910. the proportion in group one (the treatment group) is assumed to be 0.2940 under the null hypothesis and 0.5850 under the alternative hypothesis. the proportion in group two (the control group) is 0.2940. the test statistic used is the two-sided z test with pooled variance. the significance level of the test was targeted at 0.0500. the significance level actually achieved by this design is 0.0506. the primary outcome is birth weight below the 10 the percentile. the sample size was inflated by 15.0% to account for lost to follow up (attrition problem). inclusion criteria: singleton pregnancy between 13-28 weeks of gestation. pregnant women aged 18 - 35 years pregnant women with fetal abdominal circumference (ac) \< 10th percentile for gestational age (ga) on ultrasound exclusion criteria: to exclude any factors that cause iugr: chronic or gestational hypertension and/or preeclampsia premature rupture of membranes a fetus with known chromosomal and/or congenital abnormalities confirmed after delivery. multiple gestation

full history: including age, gravidity, parity and gestational age clinical examination: be physically examined. abdominal examination and measurement of symphsis-fundal height diagnosis of iugr will be confirmed by ultrasound and confirmed by doppler ultrasound of umbilical artery and cerebral artery blood flow in 3rd trimester

Eligibility criteria:
inclusion criteria: - singleton pregnancy between 13-28 weeks of gestation. pregnant women aged 18 - 35 years pregnant women with fetal abdominal circumference (ac) \< 10th percentile for gestational age (ga) on ultrasound exclusion criteria: * chronic or gestational hypertension and/or preeclampsia premature rupture of membranes a fetus with known chromosomal and/or congenital abnormalities confirmed after delivery. multiple gestation